HCPCS

ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines Step 2b

Retrieved on: 
söndag, juni 2, 2024
Consensus, Sentinel, Real-World Evidence, NPV, Privacy, Smoking, Business analyst, Interest, Scope, Section 3, Missing data, Attention deficit hyperactivity disorder, World Health Organization, Thrombosis, Vaccination, Artificial intelligence, GVP, Element, ICD-10, ICD, Target, Clutch (eggs), MedDRA, Anaphylaxis, Data collection, Multi, Registry, Infant, International Society, Collection, Incidence, Clinical study design, FD, Replication (computing), Deference, Failure, CDM, Innovation Center station, Prevalence, Diagnosis, Mortality, Pregnancy, Person, Data analysis, Classification, Committee, Knowledge, Silver, PMID, Development, Roger Hawkins (drummer), Record, Len Bias, 1113, Polypharmacy, Sensitivity analysis, Protocol, Risk, European Medicines Agency, FDA, Real, Joint, Step, Quality control, Documentation, Standard of care, Health care, Accident, Checklist, Database, Birth weight, Statistics, Communication, Natural language processing, Table, Data Governance Act, Common data model, Study, Reproduction, Quality assurance, European, BMJ, Quality, Conducting, Comorbidity, NMPA, Knowledge Organization (journal), Drug development, DHT, Conceptual, ISPE, Adrenaline, Marketing, Cancer, EHR, Phenotype, Safety, Rehabilitation, Research design, HCPCS, Treatment, Allergy, Electronic health record, Validity, Death, MAH, Quality of life, 1128, Confidentiality, Selection bias, Prescription, Machine learning, Duration, CIOMS, Vaccine, ICMJE, Injury, Workplace, Section 5, National Cancer Institute, Bangladesh Technical Education Board, Interval (mathematics), Regulation, Data quality, Management, GCP, Digital, Software, Meta-analysis, SNOMED, Section 8, Use, Biology, QC, Uncertainty, Birth defect, PPV, FDN, Publication bias, Draft, Shareware, Frailty, Disulfiram-like drug, Guideline, Publishing, Gestational diabetes, De novo, Big data, Conduct, Medication, Bias, Immunodeficiency, EMA, Social media, International Classification of Diseases, History, Name, Data management, M10, Algorithm, Ageing, Natural history, SAP, Asian literature, Disability, QA/QC, Immortal, NDC, Book, Human voice, Central Statistics Office (India), Content, Birth, Frontiers Media, Metadata, RxNorm, Data governance, GPP, Structuring, Radiology, Benzodiazepine, Lash, User experience, Theft, Methodology, Objective, RWD, COMMUNICATION, DATA, Literature, Health information management, Clinical trial, Dependent and independent variables, Research, Patient, ATC, INTRODUCTION, TB, Section 13, Contraindication, Insurance, Concomitant, Data, Index, M14, Gestational age, Data curation, Biomarker, ICH, Paper, CHMP, Medical device
Key Points: 

    Helius Medical Technologies to Exhibit at 2024 CMSC Annual Meeting, Marking a Year of Achievements: Making PoNS More Available to People with MS

    Retrieved on: 
    torsdag, maj 23, 2024
    Music City Center, CMSC, Health care, Negotiation, Therapy, CMS, Medicare, HCPCS, News, Pons, Gait, Multiple sclerosis, HSDT, Helios, Excellence, Annual general meeting, Health insurance

    CMSC’s 38th Annual Meeting runs from May 29 to June 1 at the Music City Center in Nashville, TN.

    Key Points: 
    • CMSC’s 38th Annual Meeting runs from May 29 to June 1 at the Music City Center in Nashville, TN.
    • “From the beginning, we have prioritized getting PoNS to as many people with MS and gait deficit as possible.
    • Helius also has trained a critical mass of physical therapists, who design the customized exercise regimens that are an integral part of PoNS Therapy®.
    • Removing those barriers and helping more people benefit from PoNS has been our goal since the start.”

    AppliedVR launches RelieVRx® for workers’ compensation patients, payers and physicians

    Retrieved on: 
    onsdag, maj 22, 2024
    Audio, Video, Pharmaceutical, Research, Insurance, Human Resources, Software, Mental Health, Medical Devices, Professional Services, Science, Technology, Physical Therapy, Managed Care, FDA, Neurology, Alternative Medicine, Health, Health Technology, Health Insurance, Digital health, Medicine, Patient, Doctor of Philosophy, Medicare, HCPCS, Sleep, Medicaid, Stanford University, VR, Cognitive behavioral therapy, Compensated emancipation, Veterans Health Administration, Virtual reality, Brain, Therapy, Regulation, Pain, Multimedia

    AppliedVR , a pioneer in immersive therapeutics advancing a novel approach to medicine, has launched its flagship RelieVRx® prescription therapeutic into workers’ compensation.

    Key Points: 
    • AppliedVR , a pioneer in immersive therapeutics advancing a novel approach to medicine, has launched its flagship RelieVRx® prescription therapeutic into workers’ compensation.
    • The RelieVRx device is the first comprehensive, immersive adjunctive virtual reality treatment for chronic lower back pain to ever be FDA-authorized.
    • View the full release here: https://www.businesswire.com/news/home/20240522897398/en/
      AppliedVR launches RelieVRx for workers' compensation.
    • To learn more about the workers’ compensation program, please see Workers Comp | RelieVRx .

    Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

    Retrieved on: 
    torsdag, maj 9, 2024
    FDA, CMS, Risk, SARS-CoV-2, Food, Webcast, U.S. FDA, Administration, Research and development, Pre-exposure prophylaxis, COVID-19, Patient, Immunodeficiency, Medicine, Medicare, Clinical trial, HCPCS, Vaccine

    “The recent months have been incredibly productive for Invivyd.

    Key Points: 
    • “The recent months have been incredibly productive for Invivyd.
    • At the beginning of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors.
    • The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results.
    • First Quarter 2024 Financial Results:
      Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024.

    CorMedix Inc. Reports First Quarter 2024 Financial Results and Provides Business Update

    Retrieved on: 
    torsdag, maj 9, 2024
    FDA, Sale, CMS, ESRD, Investment, Drug, Risk, Research, TPN, Patient, Nutritional science, Eastern Time Zone, Marketing, HCPCS, Pharmaceutical industry

    BERKELEY HEIGHTS, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2024 and provided an update on its business.

    Key Points: 
    • BERKELEY HEIGHTS, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the first quarter ended March 31, 2024 and provided an update on its business.
    • The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers.
    • Operating expenses in the first quarter 2024 were $15.9 million, compared with $11.0 million in the first quarter of 2023, an increase of approximately 44%.
    • The management team of CorMedix will host a conference call and webcast today, May 9, 2024, at 8:30am Eastern Time, to discuss recent corporate developments and financial results.

    Helius Medical Technologies, Inc. Announces Preliminary CMS Payment Determination of Reimbursement for Portable Neuromodulation Stimulator (PoNS®)

    Retrieved on: 
    måndag, maj 6, 2024
    HSDT, CMS, Stroke, Pons, Public, Medicare, Helios, HCPCS, Health insurance

    NEWTOWN, Pa., May 06, 2024 (GLOBE NEWSWIRE) --  Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that the Centers for Medicare & Medicaid Services (CMS) posted proposed Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rates for the PoNS Controller and Mouthpiece to be discussed at the bi-annual Healthcare Common Procedure Coding System (HCPCS) Public Meeting, scheduled for May 29, 2024.

    Key Points: 
    • For the PoNS Mouthpiece (HCPCS code A4594), CMS based pricing on the cash pay price of $4,500, resulting in a total capped payment of $3,075.53.
    • For the PoNS Controller (HCPCS Code A4593), CMS preliminarily set pricing by mapping reimbursement to existing code E0745, (Neuromuscular stimulator, electronic shock unit), resulting in a total capped fee of $1,206.53.
    • “CMS’s preliminary determination of reimbursement for both the PoNS Controller and Mouthpiece is a significant win for Helius,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.
    • The Company cannot provide any assurance that these rates will be finalized and adopted in their current amounts, or at all.

    CorMedix Inc. Announces U.S. Inpatient Commercial Availability of DefenCath® (Taurolidine and Heparin)

    Retrieved on: 
    måndag, april 15, 2024
    FDA, CMS, Risk, Safety, CLS, Heparin, Food, Kidney failure, HD, Incidence, Patient, Medicare, Taurolidine, CVC, HCPCS, Medical device

    We are proud to provide an option for adult patients who face the risk of CRBSIs.

    Key Points: 
    • We are proud to provide an option for adult patients who face the risk of CRBSIs.
    • We look forward to expanding the availability of DefenCath to the outpatient setting later this year.”
      The commencement of U.S. outpatient commercialization of DefenCath is planned for July 1, 2024.
    • If exposure to either of the above occurs, discontinue use of DefenCath and institute appropriate supportive measures.
    • To report any safety concerns including suspected adverse reactions, contact CorMedix Inc. at 1-888-424-6345 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch .

    Invivyd Receives Healthcare Common Procedure Coding System (HCPCS) Reimbursement Codes from the U.S. Centers for Medicare & Medicaid Services (CMS) Covering PEMGARDA™

    Retrieved on: 
    måndag, april 15, 2024
    Momentum, Vaccination, CMS, Risk, Safety, SARS-CoV-2, Food, Health care, Pre-exposure prophylaxis, Patient, COVID-19, Immunodeficiency, Medicare, Interim, HCPCS, Pharmaceutical industry

    In addition, CMS issued a product specific M code (M0224) covering the administration of PEMGARDA.

    Key Points: 
    • In addition, CMS issued a product specific M code (M0224) covering the administration of PEMGARDA.
    • Both HCPCS codes are effective retroactively to March 22, 2024, the date of emergency use authorization (EUA) for PEMGARDA.
    • HCPCS is a group of standardized codes that represent medical procedures, supplies, products, and services.
    • For additional information about PEMGARDA, please see the full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.

    Axena Health receives two additional positive insurance coverage decisions for Leva

    Retrieved on: 
    torsdag, april 11, 2024
    Medical Devices, Women, FDA, Health Technology, Health Insurance, Biotechnology, Health, Consumer, Pharmaceutical, UI, Urinary incontinence, Woman, BCBS, Food, Cigna, The Institute, Leva, MD, Highmark, Life, Pelvic floor, Female, Pelvic organ prolapse, Privacy, Incontinence, Overactive bladder, Storey, MBA, FACOG, Food and Drug Administration, HCPCS, Nursing

    Both positive coverage decisions became effective on April 1, 2024.

    Key Points: 
    • Both positive coverage decisions became effective on April 1, 2024.
    • “Axena Health is focused on providing evidence-based solutions through both formal clinical trials with world-class academic institutions and published real-world evidence.
    • “Two more positive coverage decisions for the Leva System means more women can access effective, first-line treatment for UI.
    • Highmark BCBS and BCBS of ND have joined Cigna in demonstrating their clear commitment to women’s health.

    Kalogon Unveils Orbiter Med: A Medicare-Approved Custom Wheelchair Cushion for Pressure Management and Postural Support

    Retrieved on: 
    torsdag, april 11, 2024
    Women, Seniors, Men, Software, Artificial Intelligence, Medical Devices, Internet, Hardware, Consumer, Consumer Electronics, Technology, Physical Therapy, Medical Supplies, General Health, Health, Apps, Applications, Health Technology, Health Insurance, Wheelchair, CMS, Risk, Safety, Heart, Machine learning, Insurance, APM, Spacecraft, Patient, Mobility, Medicare, HCPCS, Communications satellite

    For the first time, Orbiter Med combines Kalogon’s groundbreaking Advanced Pressure Management (APM) system with the individualized postural support of a custom cushion reimbursable by insurance.

    Key Points: 
    • For the first time, Orbiter Med combines Kalogon’s groundbreaking Advanced Pressure Management (APM) system with the individualized postural support of a custom cushion reimbursable by insurance.
    • However, people who use wheelchairs have had to compromise by choosing to focus on either structural support or skin integrity.
    • Orbiter Med is custom fabricated based on each patient’s unique seating and positioning requirements - needs that can’t sufficiently be satisfied by a prefabricated seating system.
    • Orbiter Med is a fully customized system that blends the best technology in pressure management with tailored stability and postural support specific to a patient’s needs."